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510(k) K052341

AJEX 9015/135H PORTABLE X-RAY by Jpi America, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2005
Date Received
August 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Jpi America, Inc.

  • K945328 — JPI X-RAY FILM CASSETTE (January 20, 1995)
  • K945327 — JPI X-RAY GRID (January 20, 1995)

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